SPECTRAFORCE · 4 hours ago

Risk Management SME

United States

Contract

Remote

Senior Level

$95/hr - $95/hr

5+ years exp

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ConsultingCRM

Growth Opportunities

Hiring Manager

Avantika Kaila

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Responsibilities

Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015

Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.

Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.

Leads development and implementation of key performance indicators and metrics for the risk management process.

Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.

Qualification

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ISO 14971 2019Risk ManagementMedical device industry experienceMDR requirementsIEC 62366-1 2015Statistical techniquesUsability EngineeringDegree in EngineeringMinitab

Required

RM SME position, experience with ISO14971:2019 is necessary.

Risk management experience should not be before 2020.

They also need to know how to apply statistics beyond process capability and SPC charts.

Must have working knowledge of ISO14971:2019, MDR requirements, and IEC62366-1:2015.

Must have experience in remediating risk management files for EU MDR.

Must have strong communication skills.

Must be able to work normal business hours.

Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical).

5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices.

Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).

Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.